Skip to main content
OpenTrials
Completed

NCT Number: NCT00119691

Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction

The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Decompensated heart failure hospitalization with at least 1 symptom and 1 sign of elevated filling pressures
  • Admission estimated creatinine clearance =< 50 cc/min.

Exclusion criteria

  • Systolic blood pressure < 85 mm Hg
  • Cardiogenic shock
  • Volume depletion
  • Myocardial infarction, unstable angina within last 30 days
  • Significant valvular stenosis, hypertrophic/restrictive cardiomyopathy, or constrictive pericarditis
  • Chronic hemodialysis
  • Anticipated major procedure during hospitalization i.e. left heart catheterization, surgery, or transplantation
  • Enrolled in another research protocol within last 30 days.

Treatment and study plan

Nesiritide

Drug

Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved.

Other names: Natrecor

Primary outcomes

  1. Renal function

    Time frame: within 7 days after randomization

Secondary outcomes

  1. Weight loss

    Time frame: Within 7 days from randomization

  2. Days to optimal volume status

    Time frame: From randomization till day 7 or sooner

  3. Concomitant diuretic use

    Time frame: Within 7 days from randomization

  4. Global symptom assessment

    Time frame: 24 hrs and 3 days after randomization

  5. Length of stay

    Time frame: From admission to discharge or day 7

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Scios, Inc.

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jul 14, 2005
Registry last updated
Sep 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.